Category Archives: surgical glue

Advanced and basic wound closure markets in contrast globally

In a prior post, I noted the migration of advanced technologies from countries/regions with well developed medical technology markets (U.S., Europe, Japan) to countries/regions such as China, which have large economies but relatively undeveloped markets for these technologies.

To elaborate on that, one of the more advanced technologies in wound closure is for the devices used in vascular closure, represented in the majority of cases by those used for closure of femoral artery puncture following diagnostic and interventional catheterization procedures. By contrast, perhaps the most basic wound closure technology is surgical tapes.

Diagnostic and therapeutic catheterizations are advanced procedures designed to reveal and treat vascular pathologies, respectively, and require access to the vasculature through a femoral artery. Following the procedure, the prompt and effective closure of the femoral puncture is critical, given the size of the artery and the potential for its inadequate closure leading to rapid blood loss and death. The overall procedure comprises advanced technology in the catheterization and the closure that is therefore relatively common in advanced economies, such as the U.S., Europe and Japan, and relatively scarce or non-existent in markets, such as China.

By contrast, surgical tapes are the simplest form of wound closure with minimal technology. However, the caseload for use of surgical tapes is enormous, given the incidence of simple lacerations that can be addressed through surgical tapes. Given advanced alternatives to closure (sealants, glues, hemostats, etc.) in the U.S., Europe and Japan, surgical tapes have considerably lower demand than in China.

The contrast is illustrated in the two forecast graphs of global sales of surgical tapes and vascular closure devices.

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Source: Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″; MedMarket Diligence, LLC.

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Source: Report #S192; MedMarket Diligence, LLC.

 

Technology Migration in Global Wound Closure Markets

Drawn from our recent report on the global market for wound closure products, Report #S192, the distribution of the technologies on the market now, and in the future, for wound closure encompassing sutures & staples, tapes, hemostats, sealants & glues and vascular closure devices reveals the continued migration of advanced technologies (vascular closure, hemostats, glues & sealants) from western economies to the developing markets. Simultaneously, the more well established technologies (tapes, sutures & staples) are showing modest growth in western economies and robust growth in developing economies.

Below are illustrated the percentage of total worldwide market for each wound closure technology type by country/region.

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Source: MedMarket Diligence, LLC; Report #S192

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Source: MedMarket Diligence, LLC; Report #S192

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Source: MedMarket Diligence, LLC; Report #S192

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Source: MedMarket Diligence, LLC; Report #S192

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Source: MedMarket Diligence, LLC; Report #S192

Country and regional forecasts for surgical sealants and glues, 2013-2018

The largest current and future market for surgical sealants and glues (at least through 2018) remains the U.S. by a fairly wide margin. Second to the U.S. is the aggregate of all Asia/Pacific countries (excluding Japan and Korea), followed by Japan (the second largest single country market for sealants & glues) and then Germany. Below is the 2013 to 2018 forecast of surgical sealants and glues, by country/region, sorted by current market size.
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Source: MedMarket Diligence, LLC; Report #S192

The U.S., Japan and Germany are well developed markets for medtech products like surgical sealants and glues; hence, their large current total sales. However, faster rates of adoption are taking place in markets that have accordingly not been penetrated to the same degree, and this becomes particularly significant for the very large current markets of the Asia/Pacific region (India and China in particular). Below is illustrated the compound annual growth rate (2013-2018) for sales of surgical sealants and glues by country/region, sorted in order of growth.

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Source: MedMarket Diligence, LLC; Report #S192

Growth and Change in $14 Billion 2018 Global Market for Sealants, Glues, and Wound Closure – New MedMarket Diligence Report

The market for products to stop bleeding, close wounds, seal wounds and ultimately optimize wound healing is a diverse and dynamic arena filled with over a hundred companies — from startups to multinational powerhouses – vying for a large caseload of acute surgical wounds. MedMarket Diligence has completed a global analysis of the products, technologies markets for surgical sealants, high strength and other glues, hemostats, tapes, vascular closure devices and other wound closure products.

The global market for sutures & staples, vascular closure devices, surgical tapes, medical and surgical hemostats and surgical sealants and glues will grow to $14 billion by 2018. Traditional methods to close and secure wounds via suture are under a steady barrage of new technologies that have gained credibility among clinicians, widespread acceptance by third party payers and a resulting caseload that is poised to gain over half the global market, according to a new report from MedMarket Diligence.

“Traditional wound closure via suture represents a fundamental skill in clinical practice, and the ease of its performance, strength of the closed wound and long presence in wound management make it a tough market to penetrate, but that is just what has happened over the past couple decades,” says Patrick Driscoll, President of MedMarket Diligence, LLC.

Fibrin sealants came on the scene, mostly outside the U.S. in the early 1990s, demonstrating the ability to effect better closure and minimize blood loss. With protocols and other reassurances that these blood-derived products would not risk HIV transmission, the U.S. market opened up as well. Subsequently, an enormous array of biologically- and chemically-based products began seriously disrupting the hundreds of years of dominance by surgical sutures. Adding to wound closure were the products demonstrating rapid hemostasis, hitting suture limitations head-on. With low hurdles to enter the market, companies proliferated and began carving up large swaths of the wound closure market. However, surgery evolved, with laparoscopic and other endoscopic procedures giving impetus to advanced sutures, clips and staples delivered endoscopically. Moreover, suture technologies also evolved, with the development of different resorbable sutures adding a level of utility and value to sutures, further buttressing their defense against the emerging novel wound closure products.

Technologies in wound closure continue to evolve and be adopted globally. The end result is that there is steady emergence and turnover (via acquisition and exits) of companies in the market.

The 2014 MedMarket Diligence report, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, covers the markets for Surgical Wound Closure products, including Sutures and Staples, Vascular Closure Devices, Medical Tape, Surgical Hemostats, and Surgical Sealants and Glues. It takes into consideration those products which are used in hospitals, medical clinics and physicians’ offices. It does not address consumer, dental or veterinary markets, nor does it include medical adhesives used in manufacturing devices intended to be used for medical applications.

The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

The report also provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2018. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

The report profiles the top companies by revenue and a reasonable selection of the most promising or otherwise noteworthy companies in the markets covered in this report, providing data on their current products, current market position and products under development.

The report is described in detail at link and may be ordered for immediate download from link.

Rising and fading technologies in the global market for wound closure

Technologies emerge, gain clinical acceptance, grow in caseload and become the standard of care. Then new technologies emerge, developed to improve on or eclipse established technologies. They gain acceptance and the cycle continues.

The pace of technology and market development in the products used in wound closure — sealants, glues, hemostats, sutures/staples, tape, and vascular closure devices — follow this path as characteristically as any medtech market. However, the pace of adoption varies both by technology type and geographic location. Consequently, there is a pretty wide range of compound annual growth rates in the sales of these product globally, regionally and by country.

Below illustrates the highest growth segment-geography combinations in the wound closure market. This frequently illustrates that novel technologies more rapidly penetrate well developed economies, which can sustain the initial high premium pricing of novel technologies, then progressively migrate to less well developed economies.  (For the sake of direct comparison, the high and low growth graphics are shown on the same scale.)

High Growth Segment-Geographies in Wound Closure

Screen Shot 2014-10-23 at 2.07.43 PMSource: MedMarket Diligence, LLC; Report #S192.

Low Growth Segment-Geographies in Wound Closure

Screen Shot 2014-10-23 at 2.07.52 PMSource: MedMarket Diligence, LLC; Report #S192.

Surgical Sealants and Glues in Wound Closure

Wound closure is a critical element of the overall wound management process. Indeed it is the most critical step in the sense that, if not accomplished promptly and effectively, can result in adverse outcomes ranging from chronic wound formation, infection and, unfortunately, death.

Sealants and glues have become an entrenched, though not dominant, aspect of routine clinical practice in wound closure. These technologies have demonstrated efficacy that has warranted their use independent of other closure technologies, such as traditional sutures and staples, or as adjuncts to them, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, where leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

It is useful to categorize surgical sealants, glues, and hemostats on the basis of their primary components and/or their intended use. The market for these products can be broken down (and has been done so in report #S192) by composition into products containing biologically active agents, products made from natural and synthetic (nonactive) components, and nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats.

Global Market

The global market for products in wound closure is comprised of large, well established, and relatively low growth segments like sutures/staples; the low volume, low growth segments like surgical tapes; and the smaller, higher growth segments like vascular closure, hemostats, and surgical sealants/glues:

Growth and Size of Major Wound Closure Market Segments

 

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Sales ($millions) are 2014; Growth is CAGR 2013-2018.

Source: MedMarket Diligence, LLC; Report #S192 (published October 2014).

 

The MedMarket Diligence report #S192, “Worldwide Market for Surgical Sealants, Glues, and Wound Closure, 2013-2018: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”, details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples, vascular closure, hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The Report provides full year actual data from 2013 and, for available companies, quarterly data from 2014. The report provides a worldwide forecast to 2018 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

The relentless proliferation of wound closure technologies

Sutures are not dead. They cling to the wound closure market as tenaciously as, well, non-resorbable sutures.

Though the mainstay in the management of acute and traumatic surgical wounds for literally hundreds of years, sutures have been giving up some of their hold on the market, as a result of a robust rate of development, introduction and clinical acceptance of a wide array of biologically-based, chemically-based or combination of chem/bio products that stop bleeding, seal wound edges to varying degrees (adjunctively and independently) and otherwise close and heal wounds. The value of these products ranges from the critical, such as in new hemostat products with the potential to revolutionize treatment of battlefield wounds, to the aesthetic, with sealants that can dramatically reduce or eliminate scarring.

As the ancient Greek philosopher Heraclitus recognized, however, you cannot put your finger in the same river twice. The surgical arena continues to change dramatically and it challenges and creates enormous incentives for manufacturers to keep pace by developing novel wound closure technologies. Laparo-endoscopic innovations from conventional laparoscopy through single port laparoscopy to natural orifice transluminal endoscopic surgery established new requirements for the manipulation of tissue and manufacturers responded with a wide range of endoscopic sutures, staples, clips and appliers to facilitate MIS procedures.  Even sutures themselves have been reengineered to dissolve in controlled ways to enhance the end result of wound closure.

But where sutures were once THE universally accepted manner to bring wound margins together, they are now challenged on all sides by fibrin and other surgical sealants, hemostatic agents, vascular closure devices, cyanoacrylate and other high strength surgical glues and even sophisticated tapes. For now, sutures hold the slim margin of dominance in this aggregate market, but by 2018, the overall market for wound closure will be represented in the majority, by products other than surgical sutures and staples:

Worldwide Surgical Wound Closure Products Market, by Device Segment, 2018

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Source: MedMarket Diligence, LLC; Report #S192